# Hope floats! FDA regulation reversal eminent?



## Bird-Dog

*Trump HHS Pick Pleases Cigar Makers*
*Fought destructive FDA regs that would kill small businesses*
BY: Bill McMorris 
December 1, 2016 4:59 am
Trump HHS Pick Pleases Cigar Makers
 
Cigar smokers and makers are hopeful that President-elect Donald Trump will provide relief to the industry, which is facing an uncertain future after the Obama administration adopted regulations that threatened the industry with crippling costs.

The Food and Drug Administration announced new rules in May that would subject premium, hand-rolled cigars to comply with product-testing and label requirements similar to those cigarettes and smokeless tobacco undergo. The agency adopted those rules, despite a letter from the Obama administration's Small Business Administration saying that it would cost small businesses between $390,000 and $759,000 upfront and present employers with $450,000 to $540,000 in additional costs annually.

SBA Chief Counsel of Advocacy Winslow Sargeant said in a letter that the FDA did not conduct a cost-benefit analysis to these costly rules.

"The [agency] does not adequately describe the costs of the proposed rule on small entities," the letter says.
Mark Pursell, president and CEO of International Premium Cigar and Pipe Retailers Association, said that the rules, which are nearly 500 pages long, ignore the differences between the premium cigar market and more common tobacco products. The FDA was granted the right to regulate the tobacco market after Congress passed the Tobacco Control Act of 2009, legislation that focused on youth access and specifically cigarettes and smokeless tobacco.

The agency floated the idea of bringing premium cigars, which have a much older user base, under its regulatory authority in 2014.

"They brought the hammer down on us and want to expose a small, artisanal industry to the full compliance, burden, and expenses that Big Tobacco deals with everyday," Pursell said. "Small manufacturers will not be able to afford the expense of bringing products to market."

The rules would force all cigar makers to present the FDA with all new blends and products introduced; only product lines introduced before February 2007 would be exempt. Purcell said that premium cigars-"the type you see at weddings"-make up just 300 million of the 14 billion cigars sold in the United States each year and the FDA said that "approximately 90 percent of domestic entities affected by this rule are estimated to be small."

These products are hand-rolled, typically in Nicaragua, Honduras, or the Dominican Republic, and do not have the vast user-base and extensive revenues that cigarette makers enjoy. He said the agency overreached in treating cigars on the same plane as cigarettes.

"Our category does not have the problem of youth access that the rest of the industry has. These cigars are sold in specialty shops that you have to be 18 [years old] to enter," he said. "You're putting 35,000 American main street jobs at risk."

Trump's selection of congressman and surgeon Tom Price (R., Ga.) to lead the Department of Health and Human Services has given the cigar industry hope that it can avoid the full implementation of those rules. Price, who declined to comment on the story, twice cosponsored unsuccessful legislation that would have clarified that premium cigars are exempt from the rules.

If confirmed, Price would have the ability to block implementation on the industry through a non-enforcement directive from the White House.

Glynn Loope, executive director of Cigar Rights of America, said his group is "hopeful that a moratorium and re-evaluation of regulations" will occur within the opening months of the Trump administration. He said the FDA "went beyond congressional intent" when it grouped cigars with cigarettes and supported the legislation that Price co-sponsored. Even large cigar companies introduce new blends or limited releases based on a specific climate or crop output; subjecting them to bureaucratic overview that is generally applied to billions of mass-produced cigarette products would "make it unaffordable to get product to market," Loope said.

"The FDA failed or didn't care about the impact this was going to have," Loope said. "We're hoping it's a new day in the neighborhood. We are heartened by what we've seen with this administration."
Pursell also welcomed the nomination, saying that Price's record in congress reflected a cautious approach to regulation.

"He takes a commonsense approach to government regulation in general," he said. "We need rules that make sense for consumers, for the public health, and for manufacturers. We don't have that right now."

The agency began implementing the new rules in August. Cigar makers have until the end of the year to register with the FDA and will begin submitting ingredient lists of products in February if the rules go into full effect.


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## Bluedragon

Here's hoping this is one of many short sighted regulations that gets removed. I suppose it will depend on his picks for the various department heads, and if he gives them leeway to curb unnecessary regulation.


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## HighRockiesPuffer

I've got my fingers crossed that they throw out the new FDA regulations 

Sent from my LG-D850 using Tapatalk


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## Tabloid Snapper

HighRockiesPuffer said:


> I've got my fingers crossed that they throw out the new FDA regulations
> 
> Sent from my LG-D850 using Tapatalk


Honestly if you feel strong about the cause, I would wait until the "NEW" FDA Chief takes office, after Trump is in office. To start a letter writing campaign to the "NEW" FDA Chief.

Individual letters & postcards draw more attention than on-line patioion, and other mess efforts. This mass online patition, etc. Do not make the impact of 100,000 letters arriving to an office, supporting or not supporting a cause in Washington, DC.


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## HighRockiesPuffer

Tabloid Snapper said:


> Honestly if you feel strong about the cause, I would wait until the "NEW" FDA Chief takes office, after Trump is in office. To start a letter writing campaign to the "NEW" FDA Chief.
> 
> Individual letters & postcards draw more attention than on-line patioion, and other mess efforts. This mass online patition, etc. Do not make the impact of 100,000 letters arriving to an office, supporting or not supporting a cause in Washington, DC.


Very true!

Sent from my LG-D850 using Tapatalk


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## Bird-Dog

Don't just send letters. Send our incoming HHS Secretary (and BOTL) Tom Price 100,000 cigars...

And a really big tupperdor. :vs_laugh:


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## Tabloid Snapper

Very good friend is a retire US Senatorial Staffer, and he said individual letter his ex bosses office received in DC, and locally back home in the state office our senators, and member of the house of representative may not be read verbatim, but ever letter on pending supporting or opposing we noted.

The reason individual letters counted so much, it take effect to send them.


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## Bird-Dog

FDA brass may be getting that funny feeling that change is coming that's going to change their changes!

Excerpt from IPCPR email blast:

_This week the FDA announced a six-month extension of the ingredient listing requirement for manufacturers and importers of newly "deemed" tobacco products (including cigars) that are on the market as of August 8, 2016. This extension pushes the submission deadline from February 8, 2017 until August 8, 2017, and provides an additional six months for small-scale manufacturers. The delay follows the FDA's similar decision earlier this month to push back the manufacturer registration and product listing deadlines by six months to June 30th, 2017_


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## Joe Sticks

These regulations, like so much of government, is completely arbitrary under 'administrative law'. These regulations were not specifically enacted by congress (supposedly the 'representatives of the people') but by bureaucrats. The regs only have 'the color of law'. Yes, there is a public comments period. No, the bureaucrats don't need to follow the public's desires, and usually don't. Usually, the public is unaware of what they even are up to.

There was a recent study at Yale. They found that if the broad citizenry strongly wants something, the odds are only 30% that it will actually be enacted. Similarly, if the public strongly wants something to end - the odds are only 30% that this will happen. On the other hand, the desires of special interests (big money & corporate) - track closely with what is put into laws and regulations.

My point in all this is that while many thought the new regs are written in stone, this is not the case. As a matter of fact, President Trump could write an executive order that would stop all the new obama administration tobacco regs dead in their tracks. (These regs came about as a way to close a 'loop hole' used by vaping companies. I suspect that there are big money interests who wanted to drive the small players out of that industry so they would have an open field. FDA redefined 'children' as adults to the age of 29 in order to 'justify' the new regs. As usual - 'follow the money' is usually a good place to start. I must qualify that this last statement is only my suspicion, I haven't looked deeper into who actually pushed these new regs that impacted a couple of relatively small industries (cigars and pipe tobacco) that had done quite fine for decades meeting their customers needs.

Bottom line- - make a lot of noise, talk about American small business & personal freedom of choice when Trump is sworn in. Take action and this bureaucratic abomination Will End !


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## konut

I recieved an email today from Cigar Aficionado with the following text:

The bill is back. Today on Capitol Hill, U.S. Representative Bill Posey (R-FL) reintroduced a house bill, called the "Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017," to block the U.S. Food & Drug Administration's efforts to impose its regulation on the premium cigar industry.

"This is about freedom for adults to enjoy a legal product and preventing small businesses from getting caught up in regulations that were never intended for them," said Posey in an official release. "The FDA is overstepping their authority and ignoring congressional intent by applying these burdensome regulations to premium cigars, which are not marketed to children."

Posey maintains that the FDA's rule could negatively impact the tens of thousands of jobs associated with cigar manufacturers and small businesses. His legislation would give an exemption to hand-rolled premium cigars from FDA regulation.

The legislation (H.R. 662) was first introduced in 2015, but the bill didn't pass under the last Congress (114th).

As of today, the reintroduced bill already has 30 co-sponsors. Typically, a bill requires about 218 co-sponsors before it's up for a vote on the floor of the House of Representatives.

"The Family Smoking Prevention and Tobacco Control Act was intended to keep teens and children from smoking," said George Cecala, spokesman for Congressman Posey on a phone call to Cigar Aficionado. "Premium cigars do not market to teenagers. We know that. The FDA has overstepped its bounds. Their regulation puts small business in jeopardy and affects the freedoms of adults to enjoy a legal product."


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## Humphrey's Ghost

Bluedragon said:


> Here's hoping this is one of many short sighted regulations that gets removed. I suppose it will depend on his picks for the various department heads, and if he gives them leeway to curb unnecessary regulation.


Unnecessary regulation pretty much describes the state of our country. Hopefully this is the beginning of getting the government out of every little tiny aspect of our business and private lives.


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## Humphrey's Ghost

Not going to say who I voted for, but God Bless America.

Cigar News: Three Congressman Send Letter to Vice President Pence Urging Suspension of FDA Regulations on Cigars


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## Bird-Dog

Humphrey's Ghost said:


> Not going to say who I voted for, but God Bless America.
> 
> Cigar News: Three Congressman Send Letter to Vice President Pence Urging Suspension of FDA Regulations on Cigars


Great link! Looks like a slam-dunk to me, especially if you read some of the related stuff linked in that article like the SBA report and the e-cig letter. The FDA's recent over-reach should be just the sort of burdensome regulations the new administration has promised to curtail.


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## phatmax

Has there been any update on the FDA regs? I am googling what I can and don't see any new stuff, just stagnant articles, etc.


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## Bird-Dog

phatmax said:


> Has there been any update on the FDA regs? I am googling what I can and don't see any new stuff, just stagnant articles, etc.


No changes yet, but it's a process.

One such notable is that Dr. Scott Gottlieb has been nominated as head of the FDA. Gottlieb has published opinions explicitly criticizing the the FDA's attack on premium cigars as an example of _"a broader trend of expanding the scope of regulation to cover areas never envisioned by Congress."_


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## UBC03

Plus with the budget gettin whacked, they'll have to choose between tainted meat and hand rolls I hope the choose meat..but it is the government so who knows.

Sent from my SM-G925V using Tapatalk


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## Bird-Dog

From IPCPR email blast today...

*FDA Compliance Deadlines Extended*
​ _Since July 15, 2016, Cigar Association of America (CAA), Cigar Rights of America (CRA), and the International Premium Cigar and Pipe Retailers Association (IPCPR) have been pursuing litigation in federal court against the United States Food and Drug Administration (FDA), challenging the FDA's May 10, 2016 Rule deeming cigars and pipe tobacco to be tobacco products subject to FDA regulation.

In the context of the litigation, the FDA has announced an extension of upcoming compliance deadlines under the deeming rule. Specifically, on May 1, 2017, the United States Department of Justice (DOJ) advised the United States District Court for the District of Columbia that the FDA will extend and defer enforcement of all future compliance deadlines under the Rule for 3 months, and that it plans to issue guidance to that effect. The DOJ informed the court that new leadership at the United States Department of Health and Human Services (HHS) wish additional time to more fully consider the issues raised in the Rule. For example, the deadline for submission of product listings, previously June 30, 2017, will now be September 30, 2017. The three month extension applies to all future scheduled deadlines whether they fall in 2017, 2018, or later.

A notice is expected to be published in the coming days further memorializing FDA's extension of compliance deadlines under the Rule._​


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## phatmax

While not direct precedent, the FAA regulation forcing drone registration was just struck down in the courts. I take this as a good sign that onerous and capricious regulatory burdens may actually be reviewed in the courts, if the fight is brought to them?. I'd say another round of letters, calls and emails to Congress critters could help stop the rubber stamping of the FDA rule.
http://thehill.com/policy/transport...down-federal-registration-rule-for-toy-drones


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## Bird-Dog

(excerpt from IPCPR email blast)

Earlier today the House Appropriations Committee passed legislation that includes language prohibiting the FDA from enforcing current regulations on premium cigars. The committee considered and voted on the FY 2018 Agriculture Appropriations bill - which provides funding for operations and programs at the FDA. The provision, supported by a majority of the committee, acutely defines premium cigars and prohibits any FDA regulations on the newly defined category for the next fiscal year.


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## NightFish

Thanks for the updates @curmudgeonista. Much appreciated.


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## markg900

This is a step in the right direction.

FDA Delays Submission Deadline for Cigar Approval to 2021 - halfwheel

The U.S. Food & Drug Administration (FDA) announced that it will be unveiling a new comprehensive tobacco policy, which amongst other things will delay the deadline for substantial equivalence from August of 2018 until to Aug. 8, 2021.

It's a three-year delay only to the approval deadline for substantial equivalence, a process by which manufacturers would submit for product approval based on reports that the cigar in question is substantially equivalent in its threat to public health, i.e. it is no more harmful than an already approved product.

To learn more about product approval, click here.

FDA has previously stated that it estimates as many as 30 percent of cigars to apply for some form of substantial equivalence, with approximately 60 percent applying for grandfather status, a process expected to be far easier and cheaper and one that four cigar manufacturers have already received approval for.

Today's announcement does not affect any of the other FDA-related deadlines such as warning plans and ad requirements, the first of which would go into effect on Aug. 10, 2017, though sources have told halfwheel they expect FDA to delay those deadlines by another three months as the agency and the Department of Justice request another three-month delay in lawsuit brought against FDA by three cigar trade groups: the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR).

In a press release, Dr. Scott Gottlieb, commissioner of FDA, indicated the agency would open a comment period for public and scientific comments regarding how consumers use cigars, the potential health effects of smoking cigars and how cigars should be tested for harmful and potentially harmful constituents (HPHCs).

While FDA has announced it will issue much more detailed substantial equivalence, it remains unclear when that guidance will come as the agency announced no specific dates other than the 2021 date and an Aug. 8, 2022 date for e-cigarettes and vapor products to submit for premarket tobacco product application (PMTA).

Earlier this month, Tobacos Mundial, a Houston-based warehouse that is also handling FDA compliance for a variety of its clients, received a letter from FDA as part of a substantial equivalence process for a product from Jas Sum Kral, one of its clients.

According to Andrew Wood of Tobacos Mundial, the 10-page response listed a variety of data FDA wanted as part of the substantial equivalence filing including the levels of nicotine, carbon monoxide, tar, pH and nitrocomine within the smoke put off by a cigar.

The agency also wanted to know the ingredients used, including those in the bands, boxes and cellophane as well as the weight and weight to surface area ratio for each tobacco component.

While the letter was problematic in the sense of being able to reply to it, many saw it is as win to prove just how egregious FDA's process would be. As part of the lawsuit, the three trade groups have argued that FDA did not fully or accurately evaluate the costs and the letter sent to wood would back that up. The agency estimated that a full substantial equivalence report, of which it predicted only 5 percent of cigars would be subject to, would cost $22,787.

It might be possible that FDA's estimates would be close to the actual costs, Wood told halfwheel because of the delay to 2021 he is waiting to actually test the cigars, it's likely the estimate about 5 percent of cigars is way off.

As part of today's announcement, there's no dates given for when FDA will open the comment period, close the comment period or announce a regulatory framework for substantial equivalence, meaning it could be a few years before any of that is announced. In the mean time, any cigars that were on the market prior to Aug. 8, 2016 will be allowed to remain on the market, so long as the comply with other regulations such as the ban on free samples, which is already in effect, and warning label restrictions, which will go into effect at some point in the future, likely before 2021.


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